02-392-5 Me. Code R. § 36-4

Current through 2024-51, December 18, 2024
Section 392-5-36-4 - Pharmacist in Charge
1.Generally

Dispensing of opioids and other prescription drugs must be conducted under the indirect supervision of a licensed pharmacist who has registered with the board as the pharmacist in charge of the opioid treatment program. No opioid treatment program may operate without a pharmacist in charge.

2.Responsibilities

The pharmacist in charge is responsible legally and professionally for all activities related to the practice of pharmacy within the opioid treatment program for which the licensee is registered as pharmacist in charge, and for the opioid treatment program's compliance with the provisions of the Maine Pharmacy Act, the rules of the board, and the federal and state laws and rules specified in Chapter 29, Section 1 of the board's rules.

The pharmacist in charge is responsible for ensuring that doses of opiate agonist treatment medications are prepared in properly labeled, patient-specific containers for delivery of such drugs to patients for consumption away from the facility. The responsibilities of the pharmacist in charge also include, but are not limited to:

A. The opioid treatment program's procedures for the procurement, storage, compounding and dispensing of drugs;
B. The recordkeeping systems required in the practice of pharmacy for the purchase, possession, storage and repackaging of drugs; and C. Ensuring that the dispensing area is operating in conformance with good pharmaceutical practices.
3.Presence of Pharmacist at Opioid Treatment Center

The pharmacist in charge of an opioid treatment program or another licensed pharmacist authorized by the pharmacist in charge shall be physically present at the facility to prepare drugs for delivery as described in subsection 2 above, except that during any state of civil emergency declared by the Governor, no pharmacist will be required to be physically present to prepare drugs for delivery, provided that such drugs are prepared by either an advanced practice registered nurse, a registered professional nurse, or a licensed practical nurse who is (1) licensed by the State Board of Nursing; (2) licensed by the board as a pharmacy technician; and (3) explicitly designated by the pharmacist in charge to prepare drugs in the absence of a pharmacist. A pharmacist need not be present when drugs are delivered to patients. As set forth in Chapter 13, Section 3(4) of the board's rules, a pharmacist's application to serve as pharmacist in charge of an opioid treatment program and one other type of non-opioid pharmacy, or two opioid treatment programs and no other non-opioid pharmacy, will be approved automatically, subject to disciplinary review.

4.Patient Counseling

A pharmacist may comply with the requirement of patient counseling set forth in 32 MRSA §13784 by ensuring that written directions for use and other information relating to proper utilization of the medication prescribed are included with each new prescription delivered by the opioid treatment program. The written information must include a telephone number at which the pharmacist in charge may be contacted by patients.

02-392 C.M.R. ch. 5, § 36-4